A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

February 24, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

June 30, 2027

Conditions
Melanoma
Interventions
BIOLOGICAL

IBI363

a mutated IL-2 cytokine fused to an anti-PD-1 antibody to combine IL-2 pathway stimulation with checkpoint blockade.

BIOLOGICAL

Pembrolizumab

Pembrolizumab is a humanized monoclonal anti-PD1 antibody

Trial Locations (31)

30032

RECRUITING

Shanxi Bethune Hospital, Taiyuan

100035

RECRUITING

Beijing Jishuitan Hospital, Capital Medical University, Beijing

100142

RECRUITING

Peking University Cancer Hospital & Institute, Beijing, China,, Beijing

110000

RECRUITING

Liaoning Cancer Hospital, Shenyang

130012

RECRUITING

Jilin Cancer Hospital, Changchun

RECRUITING

The first hospital of Jilin University, Changchun

150030

RECRUITING

Harbin Medical University Cancer Hospital, Harbin

200035

RECRUITING

Fudan University Shanghai Cancer Center, Shanghai

210000

RECRUITING

Jiangsu Provincial People's Hospital, Nanjing

RECRUITING

Nanjing Drum Tower Hospital, Nanjing

230088

RECRUITING

First Affiliated Hospital of Anhui Medical University, Hefei

250012

RECRUITING

Qilu Hospital of Shandong University, Jinan

250120

RECRUITING

Shandong First Medical University Affiliated Cancer Hospital, Jinan

300060

RECRUITING

Tianjin Cancer Hospital, Tianjin

310000

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

330000

RECRUITING

Jiangxi Provincial Cancer Hospital, Nanchang

350000

RECRUITING

Fujian Cancer Hospital, Fuzhou

400000

RECRUITING

Chongqing University Cancer Hospital, Chongqing

410000

RECRUITING

Xiangya Second Hospital of Central South University, Changsha

410031

RECRUITING

Hunan Cancer Hospital, Changsha

430000

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

450044

RECRUITING

The Third people's hospital of Zhengzhou, Zhengzhou

510000

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

530021

RECRUITING

Affiliated Tumor Hospital of Guangxi Medical University, Nanning

610041

RECRUITING

West China Hospital, Sichuan University, Chengdu

650106

RECRUITING

Yunnan Cancer Hospital, Kunming

710004

RECRUITING

Second Affiliated Hospital of Xi'an Jiaotong University, Xi’an

830000

RECRUITING

The Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi

050000

RECRUITING

Fourth Hospital of Hebei Medical University, Shijiazhuang

Unknown

RECRUITING

Henan Cancer Hospital, Zhengzhou

RECRUITING

Baotou Cancer Hospital, Baotou

All Listed Sponsors
lead

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

NCT06797297 - A Study to Evaluate the Efficacy and Safety of IBI363 Monotherapy Compared to Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal or Acral Melanoma Who Had Not Previously Received Systemic Therapy | Biotech Hunter | Biotech Hunter